LONDON (Reuters)—European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials. The European Medicines Agency‘s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on…
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The Biosimilars Debate Heats Up: Potential cost savings weighed against patient health & safety
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
Clinical Trials Confirm Secukinumab Can Effectively Treat Ankylosing Spondylitis
Secukinumab, an anti-interleukin-17A monoclonal antibody, has successfully completed multiple clinical trials, which found the intravenous treatment may be safe and effective for treating patients with active ankylosing spondylitis…
Dermatology & Immunology: Skin Issues Can Present Challenges
SAN FRANCISCO—A 40-year-old woman shows up in the clinic with scarring alopecia, with an area of hyperpigmentation on the rim of her scalp, extending from just behind the temple to behind her ears. An examination with a dermatoscope shows hyperkeratotic follicular plugging. The case—in this example, the discoid form of cutaneous lupus erythematosus (DLE)—is one…
What Listening to Lungs Might Teach About Rheumatic Disease
One of your first clinical assignments as a medical student was likely to have been the lung exam. Its key descriptors may still resonate in your mind: inspection, palpation, percussion and auscultation. Proudly parading down the hospital corridors, your newly purchased stethoscope snugly tucked inside your lab coat pocket, you carefully place its cold metal…
Rheumatology Case Report: Chondromyxoid Fibroma of the Sternum
A 47-year-old Caucasian woman presented to the rheumatology clinic with a one-year history of pain and swelling involving the wrists, hands, ankles and feet that progressively worsened. Her symptoms included generalized fatigue, morning stiffness in the hands and lower back lasting more than an hour, Raynaud’s phenomena (triphasic), photosensitivity, tightening of the skin of the…
2015 ACR/ARHP Annual Meeting: Research Offers Clues to Environmental Triggers of RA
SAN FRANCISCO—Research is revealing more clues about the environmental factors that likely play a role in triggering rheumatoid arthritis (RA) in patients who are susceptible—or that may even protect them from autoimmunity. Large-scale, lengthy population studies conducted at institutions worldwide provide in-depth data from which to identify potential triggers and protective factors for RA, from…
2015 ACR/ARHP Annual Meeting: Metabolic Pathways Linked with Inflammatory Diseases
SAN FRANCISCO—Metabolomics could one day be a treasure map of information about inflammation in rheumatic disease. There are many metabolic pathways to pursue for clues on how to reverse this damaging process. “All of these signaling pathways are interrelated and affect each other,” said Douglas J. Veale, MD, director of translational research at Dublin Academic…
2015 ACR/ARHP Annual Meeting: Research Provides Insights into Immune Regulation and Tolerance
SAN FRANCISCO—To help rheumatologists better understand the underlying mechanisms of autoimmune diseases, Mark Anderson, MD, PhD, professor of adult endocrinology, University of California, San Francisco, spoke during the 2015 ACR/ARHP Annual Meeting on ways in which immune regulation and tolerance work to ensure health in individuals who maintain tolerance to self-antigens and how these processes…
Bowing to Pressure, FDA to Reform Painkiller Approval Process
WASHINGTON (Reuters)—Bowing to pressure from lawmakers, Dr. Robert Califf, President Barack Obama’s nominee to lead the U.S. Food and Drug Administration (FDA), said on Thursday the agency would reform its process for approving opioid painkillers. Last month, Sen. Edward Markey (D-Ma.) placed a hold on Califf’s nomination, preventing it from being voted on by the…
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